Cardiac Rehabilitation Mobile-Health Fall Risk Prevention Intervention

NCT05826587 | Recruiting

• 1 other identifier: 23-001155
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this research is to see if taking part in a structured exercise plan that is designed to improve balance and muscle strength and one that can done at home helps to improve the ability to perform standard physical tasks, confidence in balance, and health-related quality-of-life

Conditions

Cardiac Rehabilitation

Outcome Measures

Primary Outcomes (4)

• Change in self-reported physical function

  Measured using the Duke Activity Status Index (DASI) a self-reported questionnaire to subjectively measure physical activity level and functional capacity. The questionnaire includes twelve questions with each question weighted differently to assign a total score. Functional capacity is graded based on the total score (i.e., Good = DASI \>31.95 or Poor = DASI \<31.95).

  Baseline, approximately 7 to 14 weeks

• Change in fall risk

  Measured using the Stop Elderly Accidents, Deaths, and Injuries (STEADI) assessment component which consists of 12 closed-ended questions. A score \>4 is considered at risk for falling.

  Baseline, approximately 7 to 14 weeks

• Change in self-reported balance confidence

  Measured using the Activities-Specific Balance Confidence Scale, a 16-item questionnaire that is scored with a Likert scale (0-100%). The subject is graded on level of confidence associated with fall risk while performing a range of daily activities with varying levels of difficulty. Higher scores greater confidence.

  Baseline, approximately 7 to 14 weeks

• Change in health-related quality of life

  Measured using the Dartmouth Primary Care Cooperative Information Project (COOP), a nine-question quality of life survey. There are nine categories including: physical condition, emotional condition, daily work, social activities, change in condition, overall condition, social support, quality of life and pain. Subjects will be graded with a total and sub-category score. Total scores range from 9-45 and a lower total score indicates a higher quality of life.

  Baseline, approximately 7 to 14 weeks

Study Arms (2)

Control group of cardiac rehabilitation only

ACTIVE COMPARATOR

Behavioral: Cardiac Rehabilitation & Exercise Prescription; Other: Connected mHealth mobile application

Intervention group of additional balance and muscle strength training

EXPERIMENTAL

Behavioral: Home-based, m-Health Delivered Physical Function Training; Behavioral: Cardiac Rehabilitation & Exercise Prescription; Other: Connected mHealth mobile application

Interventions

Home-based, m-Health Delivered Physical Function Training BEHAVIORAL

An individualized home exercise physical function training will be prescribed. This would include 5 balance training exercises and 1-2 upper and lower-body muscular conditioning exercises (i.e., wall push-up and chair stand) prescribed 3 days/week over the course of a 6-week period. Subjects will be assigned exercises from 1 of 3 different levels of exercise progression based on performance during the baseline muscular fitness assessment (functional chair stand and static chest throw).

Intervention group of additional balance and muscle strength training

Cardiac Rehabilitation & Exercise Prescription BEHAVIORAL

Standard, clinically indicated cardiac rehabilitation and exercise program. Approximately 30 to 40 minutes of aerobic exercise within a prescribed rating of perceived exertion (RPE 11-14) and/or target heart rate and approximately 15 to 20 minutes of both upper and lower body resistance exercise up to three times per week for up to at least 12 weeks. In addition, subjects are provided with home exercise instructions, and will be expected to exercise for 30 to 60 minutes at home.

Control group of cardiac rehabilitation only; Intervention group of additional balance and muscle strength training

Connected mHealth mobile application OTHER

Mobile application that allows subjects to track their independent home exercise with the option of heart rate monitoring by connecting to an external heart rate monitoring device.

Control group of cardiac rehabilitation only; Intervention group of additional balance and muscle strength training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients referred to and who undergo early outpatient CR irrespective of diagnosis will be eligible for the study.
• All participants must have access to a smart mobile device.

You may not qualify if:

• Advanced dementia.
• Wheelchair bound.
• Vision loss.
• Patients that underwent sternotomy within 12-weeks will be excluded from the upper body muscular strength/power assessment and associated upper body training. At the time of enrollment into CR, balance, upper body muscular fitness, and lower body muscular fitness will be assessed in each subject before they are randomized at a 1:1 allocation ratio into one of two parallel groups:
• Standard early outpatient center-based supervised CR only (control; CR); or
• Early outpatient center-based supervised CR plus individualized, home-based, m-Health delivered physical function training (experimental group; CR+PFt). Balance, upper body muscular fitness, and lower body muscular fitness and gait will be reassessed in each participant after 5-to-6 weeks of CR and again upon completion of the CR program. Patient reported measures of fall risk will be measured at baseline with the Stop Elderly Accidents, Deaths, and Injuries (STEADI) tool kit. Balance confidence, health-related quality of life, physical activity level, and functional capacity will be evaluated before and after CR and CR+PFt using the Activities-Specific Balance Confidence (ABC) Scale, the Dartmouth Primary Care Cooperative Information Project (COOP) charts, and the Duke Activity Status Index (DASI).

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

RECRUITING

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Cardiac Rehabilitation

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Robert Scales, PhD, MS

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Scales, PhD, MS

CONTACT

480-791-8935; scales.robert@may.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 12, 2023
• First Posted: April 24, 2023
• Study Start: October 9, 2023
• Primary Completion: January 5, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)